Low dead space syringe with pivoting needle guard

Abstract

A low dead space syringe having a pivoting guard on a fixed needle assembly permanently attached to the syringe. The syringe includes a syringe barrel having an open distal end with a coupler extending therefrom; a hub having a proximal end, a distal end, and a conduit therethrough, the proximal end of the hub having a plug extending therefrom and into the coupler of the open distal end of the syringe barrel; a needle cannula having a proximal end, a distal end, and a lumen therethrough, the proximal end of the needle cannula mounted within the conduit of the hub; and a guard rotatably mounted on the hub to rotate from an open position to a locked safety position, wherein when in the locked safety position, the guard covers the distal end of the conduit.

Description

Technical Field

[0001] This invention relates to a low dead space syringe having a pivot-protected needle guard on a fixed needle assembly, the fixed needle assembly being permanently attached to the syringe, such as... Figure 1 As shown. Background Technology

[0002] Low dead space (LDS) syringes with an integrally molded hub and fixed needle (FN) (Figures 2a-2b) are widely used in the medical field, most commonly for insulin or vaccine syringes used for small doses (<1 ml) with limited and expensive medications. Another two-piece style of LDS syringe with a fixed needle (FN) features a molded syringe barrel with a separate molded hub permanently attached during manufacturing (Figures 3a-3b). The main advantage of these FN syringes is the reduction or near-elimination of dead space, thus saving medication.

[0003] Other conventional molded syringes 400 and needles 401 include Luer 6% tapered detachable syringes, as shown in the example in Figure 4. The syringe barrel may have a locking threaded ring for securely holding the needle in place. Due to industry design requirements specifications for such Luer 6% tapered medical connectors, the size range of needles and syringes is extensive. These design specifications intentionally allow space between the mating male part (typically the syringe) and the female part (typically the needle hub) to ensure they fit correctly. Other influencing factors include plastic manufacturing, where molding the female part Luer hub in plastic manufacturing requires additional space beyond the Luer sealing surface to increase the overall space. All this accumulated space between the syringe tip and the needle cavity, as well as the inner bore of the syringe tip, causes medication to be trapped and remain after injection, as shown in the shaded area 402 in Figure 5, resulting in the waste of valuable medication.

[0004] Another type of syringe currently in use includes a needle guard 61 pivotally connected to a ring 62, which is press-fitted to the distal end 63 of an integral syringe 60. The ring 62 may have the needle guard 61 integrally molded thereto with a movable hinge 64 (as described in U.S. Patent 7,648,480, FIG. 6), or it may have a device 65 for connecting the needle guard 61 (as shown in U.S. Patent 7,722,572, FIG. 7-8). In all these cases, the technology is limited by the plastic material used in the ring and the mating syringe body. The nature of plastic materials is that when two mating parts are press-fitted together, the resulting circumferential stress will cause material creep in either or both parts until a relaxation point is reached. When the plastic relaxes (which may take only a few hours or months), the parts will no longer have the desired tight fit, and the parts can easily move or rotate relative to each other, even unintentionally during the activation of the needle guard. Increasing interference by making one of the parts smaller or larger will only increase the stress, which will accelerate relaxation and reduce the desired fit. Other factors at play in press-fit ring technology are heat and radiation, which also affect the interference fit and slack between mating parts. When the design allows unrestricted movement (denting or expanding) in certain directions, the slack between the mating parts can cause them to creep and move.

[0005] The aforementioned patent applies ring technology to an integrated syringe with a hub integrally molded into the distal end of the syringe barrel, into which the needle is attached before the needle guard is connected. Another drawback of this type of design is that assembling the needle guard onto the complete syringe during manufacturing can cause the ring to damage sharp needle tips when passing over them. In this case, the entire syringe and needle guard would need to be discarded, which is not only costly but also increases waste recycling and negatively impacts the environment.

[0006] As mentioned above, the press-fit ring technology can also result in the needle protector being loosely attached to the syringe, which could cause the needle protector to rotate when the user attempts to activate it. This movement could have potentially serious consequences if the user is accidentally pricked by a used, contaminated needle during protection. The balance of forces in this type of technology is difficult to control when attempting to make the ring tight enough to prevent rotation during activation, yet loose enough for the user to rotate the protector to position it at the bevel of the needle in some procedures.

[0007] Needle ejection is another serious safety issue that can be caused by interchangeable needles not properly secured to the syringe barrel tip (where the connection force between the needle hub and syringe tip exceeds the actuation force). This needle can be inadvertently removed when the user attempts to activate the needle guard because the direction of the force activating the needle guard is the same as the direction in which the installed needle is removed from the syringe tip. This invention relates to a permanent, factory-attached hub syringe connection that eliminates this concern. Summary of the Invention

[0008] Exemplary embodiments of the present invention at least solve the aforementioned problems and / or disadvantages, and provide at least the following advantages. The present invention relates to a low dead space syringe having a pivoting protective needle guard on a fixed needle assembly permanently attached to the syringe.

[0009] In one exemplary embodiment, the low dead space syringe assembly includes a syringe barrel having a chamber for holding fluid and an open distal end having a coupling extending therefrom, the coupling connecting to a distal wall opening in the chamber; and a needle assembly having a hub, a needle tube, and a guard rotatably mounted on the hub to rotate from an open position to a locked safe position, wherein, in the locked safe position, the guard covers the distal end of the needle tube, and the proximal end of the hub has a plug extending therefrom and into a coupling in the syringe barrel to connect a conduit in the hub to the chamber such that the proximal end of the conduit is substantially flush with the distal wall opening in the chamber. With this configuration, the dead space in the syringe is minimized while still providing a needle guard for pivoting protection on a fixed needle assembly permanently connected to the syringe barrel.

[0010] As used herein, the term "far" and its derivatives shall refer to the direction toward the patient, while the term "near" and its derivatives shall refer to the direction away from the patient. It should also be noted that other objects, advantages, and salient features of the invention will become apparent to those skilled in the art from the following detailed description of exemplary embodiments of the invention, taken in conjunction with the accompanying drawings. Attached Figure Description

[0011] The invention will be more fully understood from the following detailed description, taken in conjunction with the accompanying drawings, wherein:

[0012] Figure 1 This is a side view of a low dead space syringe according to the invention, which has a pivoting protective needle guard on a permanently connected fixed needle assembly.

[0013] Figures 2a-2b are side and cross-sectional views of an existing insulin injector with a hub integrally molded to fix the needle.

[0014] Figures 3a-3b are side and cross-sectional views of an existing insulin syringe with a fixed needle having a molded syringe barrel permanently fitted with a separately molded hub.

[0015] Figure 4 is a side view of a conventional syringe with a Luer detachable needle hub assembly;

[0016] Figure 5 is an enlarged cross-sectional view of the distal end of the Luer needle hub assembly attached to the syringe shown in Figure 4, showing the waste drug contained in the dead space.

[0017] Figure 6 is an exploded side view of an existing fixed-needle syringe that houses an annular ring having a needle guard connected by a movable hinge.

[0018] Figure 7 is a side view of the ring, with other devices for connecting the needle protection device;

[0019] Figure 8 is an assembled side view of an existing fixed-needle syringe, to which the annular ring and needle guard shown in Figure 7 are attached;

[0020] Figure 9 It is based on the present invention Figure 1 The diagram shows an enlarged exploded cross-sectional view of the distal end and needle assembly of the low dead space syringe.

[0021] Figure 10 It is based on the present invention Figure 1 and Figure 9 An enlarged cross-sectional view of the needle assembly shown, on which a needle guard is attached;

[0022] Figure 11 This is a perspective view of the needle protection device of the present invention;

[0023] Figure 12 yes Figure 11 An enlarged sectional view of the pivot on the needle protection device shown.

[0024] Figure 13 This is a perspective view of another embodiment of the needle protection device of the present invention;

[0025] Figure 14 yes Figure 13 An enlarged sectional view of the pivot on the needle protection device shown.

[0026] Figure 15 yes Figure 1 The diagram shows a perspective view of the distal end of the low dead space syringe of the present invention and its permanently connected fixed needle assembly, wherein the pivot needle guard is in the unlocked position and the needle protection cap has been removed.

[0027] Figure 16 yes Figure 1The image shows a side view of the distal end of the low dead space syringe of the present invention.

[0028] Figure 17 This is a perspective view of the distal end of the low dead space syringe of the present invention, wherein the pivot needle protection device of the fixed needle assembly is in a locked safe position.

[0029] Figure 18 This is a side view of a low dead space syringe according to the present invention, which has a pivot-protective needle guard on a permanently connected fixed needle assembly having a normal length syringe barrel and an optimal length syringe barrel.

[0030] Figure 19 This is a perspective view of another embodiment of the Luer conical syringe and safety needle assembly of the present invention;

[0031] Figure 20 It is attached to the Luer cone syringe. Figure 19 The side view of the safety pin assembly shown; and

[0032] Figure 21 yes Figure 20 The image shows a cross-sectional view of the assembled safety needle assembly and the Luer cone syringe. Detailed Implementation

[0033] refer to Figure 1 The low dead space fixed needle injector 100 includes a permanently connected, separately molded needle assembly 106 having a hub 102 with a connected pivot-protective needle guard 101. The injector dead space is the volume of residual fluid retained within the injector assembly after the plunger 104 has been fully depressed during drug injection. Compared to a conventional detachable Luer cone injector 400 with a matching Luer cone hub 401, the low dead space fixed needle injector can reduce wasted drug by 30 times. Figure 1 As shown, the needle hub 102 of the needle assembly 106 is preferably connected to the syringe barrel 103 of the syringe 100 via a press-fit fluid-sealed interference fit. The hub 102 on the needle assembly 106 is preferably made of plastic. However, the syringe barrel 103 may be made of glass or plastic, and a press-fit fluid-sealed interference fit is still provided.

[0034] During manufacturing, the needle hub 102 is permanently mounted onto the syringe barrel 103. For example... Figure 9As shown, the needle hub 102 includes a needle tube 911 extending from its distal end and a needle hub cavity 901 proximal to its proximal end, the needle hub cavity 901 allowing the cylindrical nozzle tip 902 to engage and permanently connect with the needle hub 102. A sealing plug 903 is contained within the needle hub cavity 901, and because the outer diameter of the sealing plug 903 is larger than the internal orifice 904 of the cylindrical nozzle tip 902, an interference fit creates a fluid seal when the sealing plug 903 mates with the internal orifice 904 of the cylindrical nozzle tip 902. The permanent connection between the sealing plug 903 and the cylindrical nozzle tip 902 is provided by a locking ring 913 surrounding the cylindrical nozzle tip 902, the locking ring 913 engaging with a locking groove 914 on the inner surface of the needle hub cavity 901, and the locking ring 913 thereby maintaining the sealing engagement of the sealing plug 903 with the internal orifice 904. When the sealing plug 903 is attached to the tip 902 of the cylindrical nozzle, the sealing plug 903 may occupy all or almost all of the internal orifice 904 and may stop at the distal wall opening 916 of the syringe fluid chamber 905, or even minimally enter the region of the syringe fluid chamber 905, to eliminate any and all dead space when mated to the syringe barrel 103. The sealing plug 903 may include a conduit 906 that allows bidirectional access between the internal fluid chamber 905 of the syringe barrel 103 and the needle tube 911 and extends through the needle lumen 907. The distal end of the needle hub 102 includes a septum 917 and a lumen 908 for permanently securing the needle tube 911 together, typically using an adhesive material 909. A needle guard cap 910 is removably mounted at the distal end of the needle hub 102 to protect the sharp, beveled tip 915 of the distal end of the needle tube 911.

[0035] like Figure 10 As shown, the present invention also includes a needle protection device 101, which is connected to and rotatable to a permanently installed fixed needle hub 102, preferably via an interference clamping C-shaped retaining ring 1001 and a retaining ring opening 912 (as shown). Figure 9 As shown), the buckle opening 912 engages with the pivot 1002 of the needle protector 101. This arrangement allows the needle protector 101 to be in an unlocked position (e.g., before handling or during use). Figure 1 and 15 (As shown) Easily rotate to the final locked position (as shown) Figure 17 (as shown), or in the desired optional intermediate position. The needle guard 101 can also be connected to the fixed needle hub 102 via other known mechanical hinges or integrally molded movable hinges, making the needle hub 102 and the needle guard 101 a single molded part. The rotatable engagement between the pivot 1002 of the needle guard and the C-ring 1001 allows the user to selectively position the needle guard 101 during operation and maintain it in the desired intermediate position.

[0036] like Figure 12 and 14As shown, the pivot 1002 of the needle guard 102 includes one or more brakes 1101 that extend beyond the circumference of the pivot 1002 to intentionally generate friction between the pivot 1002 and the C-shaped retainer 1001. Figure 11 As shown, the brake 1101 may include a raised area located at a concentrated position on the pivot 1002, or as Figure 13 As shown, the extension pivot 1002 is of a length less than or equal to its full length. When the brake 1101 is located in the release area 1003 of the opening portion 912 of the C-shaped retainer 1001 and / or the bearing contact surface 1004 of the C-shaped retainer (e.g., Figure 10 When (as shown), the needle guard 102 remains in its open position, and the pivot 1002 travels along the bearing contact surface 1004. Placing the brake 1101 in an area where the feature is not exposed to the compressive load of the C-ring 1001 after assembly and before use (within its shelf life) helps maintain the desired frictional fit during use. If necessary, additional frictional fit between the C-ring 1001 and the pivot 1002 can be released by including a release area 1003 in the active mode orientation. Positioning the friction feature in the ring opening 912 or the release area 1003 to maintain stable protection in the packaging position also contributes to the automation of the packaging process.

[0037] A preferred embodiment of the needle protection device 101 includes a user-controlled manual lock that is activated shortly after injection and before disposal. The user activates the needle protection device 101 by rotating it on the syringe 911, typically by applying force with a finger or a hard surface. In a preferred embodiment, the needle protection device 101 includes a one-way safety lock. Figure 15 As shown, the needle protection device 101 includes two protective sidewalls 1301, each having two locking tabs 1302 at its end closest to the pivot 1002. Each locking tab 1302 extends inward into the needle and hub passage 1303. When the needle protection device 101 is activated, the locking tab 1302 deflects outward upon encountering the hub locking member of the needle hub ramp 1304, as... Figure 16 As shown, they continue until they bypass the ramp 1304 and bend back to the position where the locking unit is formed. Figure 16 As shown, the hub locking member 1400 is located on the side of the needle hub 102 opposite to the C-shaped retaining ring 1001. Locking the needle guard 101 onto the needle hub 102 produces an audible sound and a tactile sensation. This lock is for single use only. Other locking mechanisms can be used to lock the needle guard 101 onto the needle hub 102, such as a one-way barbed pin that enters a mating hole.

[0038] The preferred embodiment also includes at least one needle hook lock 1501. The needle hook lock 1501 is received within the needle and hub channel 1303 and may be connected to a side wall 1301 or extend from a support post 1502 mounted on a wall connected to the side wall.

[0039] In the preferred embodiment (hub and needle lock structure), when the needle guard 101 rotates to the desired locking position, the double locks engage almost simultaneously, such as... Figure 17 As shown. The needle hook lock 1501 is a narrow, deflecting, resilient cantilever hook that bends inward (in the opposite direction of needle approach) when the needle tube 911 is forced against it, allowing the needle tube 911 to pass around it, and springs back once the needle tube 911 has completely passed the needle hook lock 1501, confining the needle tube 911 within the needle guard 101, which prevents the needle tube 911 from retracting. When more than one flexible needle hook lock 1501 is included, the needle locks can be positioned relative to each other along the tube. In other embodiments, only one of the two locking systems (hub or needle) is included.

[0040] like Figure 11 and 13 As shown, the transverse member wall 1201 of the needle guard connecting the two side walls 1301 includes a finger-guided inclined / bending surface 1202 at the end opposite to the pivot 1002. When the needle guard 101 is in the initial open position, the needle guard 101 is almost horizontal with the syringe barrel 103, as... Figure 1 As shown, the finger-guided tilt / bend surface 1202 allows the user's fingertips to approach between the needle protection device 101 and the syringe barrel 103, so as to enable the needle protection device 101 with one hand using a basic level of finger travel.

[0041] Syringes for skin injections are typically available in standard capacities of 1ml, 2ml, 3ml, 5ml, and 10ml. For each volume, the syringe length is optimized based on the volume and graduations marked on the unit, allowing the user to precisely set the plunger to the dosage mark. Vaccine immunization usually requires a small fraction of the minimum 1ml syringe. Figure 18 The optimal syringe assembly of the present invention shown has been shortened to eliminate unnecessary portions of the barrel and plunger rod, which lead to increased cost, manufacturing challenges (see barrel bending in the section below), and environmental waste. The smaller footprint of these shorter syringes will result in additional cost savings, including savings in packaging, transportation, and handling costs. Figure 19 , 20As shown in Figure 21, the safety needle assembly 206 according to the invention can alternatively use a Luer tapered connection to connect to the syringe barrel 203, the Luer tapered connection having a female Luer tapered shape in the cavity 205 of the hub 202 and a male Luer tapered shape on the barrel tip 204 of the syringe barrel 203. The Luer tapered connection also provides a liquid-impermeable seal between the inner hub cavity 205 and the outer surface of the barrel tip 204.

[0042] It should also be noted that the present invention applies to stand-alone syringes that do not require flexible packaging but use plastic caps to maintain sterility; reusable anti-reuse (RUP) syringes with a fragile plunger feature that prevents reuse after injection (as shown and described in EP0925083B1); and fixed-dose automatic failure (AD) syringes with a plunger locking element feature that prevents reuse during and / or after plunger movement during the injection phase (as shown and described in U.S. Patent 9205205).

[0043] This invention also provides a low dead space syringe with a protective sleeve designed for healthcare workers or patients, which can be easily and safely activated without concern about rotation or ejection during needle protection activation—an advantage already disclosed previously. Preventing accidental rotation of the needle protection during activation eliminates the risk of potential needlestick injuries. This potential problem is solved by mounting the needle protection to a needle hub adapter without rotating the device. Permanently securing the needle hub to the syringe barrel and mounting the needle protection directly to the hub also eliminates the danger of the needle ejecting from the distal end of the syringe if it is not securely held by the user, a danger that occurs in Luer sliding detachable needles and syringes. Another advantage of this invention is the low profile of the needle protection, which allows unobstructed observation of the injection site and needle tip position before injection into the patient. The low profile helps reduce the likelihood of the needle protection snagging on loose clothing or bedding and being damaged or causing needlestick injuries. Figure 11 and 13 As shown, another beneficial design feature is that the distal end of the needle protector (close to the user before activation) has a sloping reverse ramp or curved area 1202, which allows the user to be guided to place their fingertips between the underside of the needle protector 101 and the syringe barrel 103 to easily initiate a one-handed preferred activation method for the needle protector to the activation position. Compared to Luer needle hubs and Luer syringe assemblies, this design achieves and maintains less wasted space, or even no wasted space.

[0044] Compared to a one-piece syringe barrel, the two-piece syringe barrel of the present invention also offers an improvement in manufacturability because the metal core pin forming the fluid chamber of the molded barrel is held in place by a support pin at the distal end. This support pin has a much larger diameter and stiffness within the mold, minimizing core displacement (bending), a major factor causing syringe barrel bending during molding, which is undesirable. When the proximal and distal ends of the syringe barrel are not aligned with the horizontal axis of the syringe barrel cylinder, an "arch" (banana shape) occurs, leading to alignment problems during assembly. Alternatively, reducing the overall length of the barrel also facilitates the molding of an optimal straight concentric barrel.

[0045] In some injection practices, such as intradermal injections, it is desirable for the needle bevel 915 to be oriented relative to the needle guard 101. This can be easily achieved by the present invention during the manufacturing process of mounting the needle tube 911 in the needle hub 102, thereby eliminating the need for the user to rotate the needle guard during use.

[0046] This invention also allows for color coding of the needle hub 102 by coloring the raw materials, enabling quick and easy identification of the specifications of the ideal needle tube 911; as described in this invention, molding the needle hub 102 separately from the syringe barrel 103 allows for this improvement over a monolithically molded needle hub syringe. A monolithically molded hub syringe cannot offer color selection because the syringe barrel needs to be made of a transparent material so that the fluid contents can be easily observed.

[0047] Reading the syringe barrel graduations is also important for healthcare professionals preparing syringes for medication. When manufacturing the syringe barrel 103 and needle hub 102 with the needle guard 101 of this invention, the needle guard 101 can be positioned for optimal viewing of the graduations. Another advantage of allowing the manufacturer to position the needle hub 102 and needle guard 101 is that it aligns the needle guard 101 with the finger pressure flange 107 of the syringe 103, minimizing syringe packaging.

[0048] As those skilled in the art will recognize, the invention is not limited to these arrangements.

Claims

1. A safety syringe assembly, comprising: A syringe barrel having an open proximal end, a first cylindrical portion extending from said proximal end to a distal end; a cylindrical nozzle tip extending from the first cylindrical portion to the distal end and terminating at the open distal end, the cylindrical nozzle tip defining an outer diameter smaller than that of the first cylindrical portion; and a cavity for retaining fluid between the open proximal end and the open distal end, wherein the cylindrical nozzle tip includes an inner bore extending from the open distal end to the proximal end to a distal wall opening located at the interface between the cylindrical nozzle tip and the first cylindrical portion, the inner bore defining a portion of the cavity, and an outer surface surrounding the inner bore, the outer surface defining a radially outwardly projecting locking ring spaced apart from the open distal end; and A needle assembly capable of being mounted onto a syringe barrel, the needle assembly comprising: A hub having a proximal end, a distal end, and a conduit passing through therethrough, the hub including a septum located at the distal end, a cylindrical plug extending from the septum to the proximal end, and an annular collar extending from the septum to the proximal end, spaced from and surrounding the plug, wherein... When the needle assembly is mounted to the syringe barrel, a plug extends into the inner bore of the cylindrical nozzle tip without extending through the distal wall opening, wherein the plug defines an outer surface sized to interfere with the inner bore of the cylindrical nozzle tip into which the plug extends, thereby forming a sealing engagement, wherein the collar defines an inwardly facing locking groove, and wherein the locking groove is configured to receive engagement with a locking ring defined on the cylindrical nozzle tip, wherein the plug extends into the inner bore of the cylindrical nozzle tip to maintain a sealing engagement between the plug and the inner bore; A needle tube having a proximal end, a distal end, and an inner lumen therethrough, wherein the needle tube extends along a large portion of a plug through the conduit and approaches the proximal end of a hub, and wherein a first portion of the conduit extends from the proximal end of the hub to the proximal end of the needle tube to define an open flow path between the proximal end of the hub and the proximal end of the needle tube. and A protective device, rotatably mounted on the hub, is provided to rotate from an open position to a safe position, wherein, when in the safe position, the protective device covers the distal end of the syringe. The inner lumen of the needle tube is connected to the cavity of the syringe barrel through the first part of the conduit, and the needle assembly is mounted on the syringe barrel.

2. The safety syringe assembly according to claim 1, wherein, The protective device can be rotatably mounted on the hub using a hinge.

3. The safety syringe assembly according to claim 2, wherein, The hinge is a pivot hinge, which has a pivot on the protective device, and the pivot is accommodated in a pivot mounting ring on the hub.

4. The safety syringe assembly of claim 3, wherein, The protective device can be independently positioned by the user between the open position and the safe position.

5. The safety syringe assembly according to claim 2, wherein, The hinge is a movable hinge that connects the protective device to the hub.

6. The safety syringe assembly of claim 1, wherein, The protective device has a tapered distal end to provide a gap between the protective device and the syringe barrel when the protective device is in the open position, thereby facilitating user activation.

7. The safety syringe assembly of claim 1 further includes a plunger rod having a distal end and a proximal end, the plunger rod being slidably mounted within the cavity of the syringe barrel.

8. The safety syringe assembly of claim 7, wherein, An annular stop wall facing the proximal end extends around the distal wall opening between the tip of the cylindrical nozzle and the first cylindrical portion, and wherein, when the needle assembly is mounted to the syringe barrel, the dead space between the distal end of the needle tube and the distal end of the plunger rod does not exceed 10 μL when the distal end of the plunger rod abuts against the stop wall.

9. The safety syringe assembly of claim 7, wherein, An annular stop wall facing proximal to the distal end extends around the distal wall opening between the tip of the cylindrical nozzle and the first cylindrical portion, wherein the distal end of the plunger rod includes a stop, and wherein the dead space between the distal end of the needle and the stop does not exceed 10 μL when the stop of the plunger rod is adjacent to the stop wall.

10. The safety syringe assembly of claim 1, wherein, When in the safe position, the protective device locks to the hub.

11. The safety syringe assembly of claim 1, wherein, When in the safe position, the protective device confines the needle within the protective device.

12. The safety syringe assembly of claim 1, wherein, When in the safe position, the protective device locks to the hub and confines the needle tube within the protective device.

13. The safety syringe assembly of claim 1, wherein, When entering the safe position, the protective device provides an audible sound.

14. The safety syringe assembly of claim 1, wherein, The protective device provides tactile feedback when the user enters the safe position.

15. The safety syringe assembly of claim 1, wherein, The hub is permanently mounted on the syringe barrel.

16. The safety syringe assembly of claim 7, wherein, The plunger rod includes a brittle feature to prevent reuse.

17. The safety syringe assembly of claim 1, wherein, The safety syringe assembly includes a fixed-dose capacity.

18. The safety syringe assembly of claim 7, wherein, The safety syringe assembly includes a locking element feature for an automatically disengaging plunger rod to prevent reuse of the plunger rod.

19. The safety syringe assembly of claim 1, wherein, The syringe barrel includes graduations on its outer surface, and when the needle assembly is mounted to the syringe barrel, the protective device is configured not to cover the graduations when in the open position.

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